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Medical Device and Medical Technology companies often devote significant resources to ensuring that their products meet quality standards and regulations at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market activity. Consequently, optimal resource levels, staffing, and structure can help quality function leaders in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth and sustainability.

Best Practices, LLC conducted this benchmarking study to provide insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.

The study also contains insights from five medical device leaders around the quality function and its future direction. Medical device leaders in quality or a related function can use this study to compare their spend and FTE levels as well as their organizational responsibility with those of leading companies.KEY TOPICS

Executive Summary

Quality Organization Cost & Staffing

Quality Organization Structure

Quality Systems

Future Directions of Quality Organization

SAMPLE KEY METRICS

Number of products on the market, Class I, II and III

Regions in which medical devices directly sold and sold through a distributor

Percentage of medical device revenue from outside the United States

Total cost of Quality function for medical devices and related services

Number of FTEs working on medical devices and related services within the Quality function

Number of direct reports for a dedicated Quality employee at each level

Responsibility allocation for tracking the risk of specific products through the lifecycle

Expectations for staffing within the Quality function the next three years

SAMPLE KEY FINDINGS

Quality Structure: Almost half, or 45%, of benchmarked Quality function structures are Distributed-Quality Centric. Only 18% of the benchmark class reported a Business-Unit Centric function.

Future Directions for the Quality Organization: Only 9% of benchmark companies expect staffing to decrease substantially in the next three years. Regulatory scrutiny is expected to increase substantially. Critical success drivers for the future Quality function will focus on having adequate resources, the impact of proposed regulations, achieving improved performance, and implementing better tools.

METHODOLOGY

For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.